A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors (NCT05731271)
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to test the safety of TST003 in patients with cancer. The main question\[s\] it aims to answer are: * What is the recommended dose patients can safely receive? * How long does this drug remain in the body after administration? * What are the side effects of this drug? * Does your cancer respond to TST003? * Participants on this study will get TST003 intravenously (through a needle into your vein), once every 3 weeks. * You may need to come to the study site 2-4 times to have tests to see if you are eligible to be in the study before you begin to receive the study drug. * After you start the study drug, you will need to return to the site several times after each dose so the physician can take vital signs, draw blood samples, and evaluate you for safety and wellbeing. * Participants will continue taking the drug as long as they are receiving clinical benefit. * At the end of your study participation, additional testing is required.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (26 items).
Location: OHSU — Portland, Oregon
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Untreated or symptomatic central nervous system (CNS) metastases. Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroid for at least 4 weeks following CNS -directed therapy are eligible for study entry.
- Prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, or targeted therapy or herbal medicine) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug.
- Radical radiation or local-regional therapies (transarterial chemoembolization or radiofrequency ablation) within 4 weeks prior to the first dose of study drug; palliative radiotherapy to a non-target lesion within 2 weeks prior to of study drug.
- Any unresolved Grade 2 or greater toxicity from previous anticancer therapy except alopecia.
- Any herbal medicine without anti-tumor intent within one week before the first dose of study drug.
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases, including but not limited to pulmonary fibrosis, active pneumonitis.
- Severe cardiovascular disease, including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina, New York Heart Association (NYHA) class III or IV heart failure or uncontrolled arrhythmia within 6 months of the first dose.
- Has the average corrected QT interval by Fridericia's formula (QTcF) prolongation to \> 480 millisecond (ms) based on 12-lead ECG in triplicate, or with a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives).
- Uncontrolled hypertension (systolic pressure \>150mmHg or diastolic pressure \> 90mmHg).
- Severe intestinal disease, including but not limited to:
- Peptic ulcer disease in the past 3 months prior to the first dosing.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- OHSU — Portland, Oregon
- Mary Crowley — Dallas, Texas
- NEXT Oncology — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.